TuHURA Biosciences, Inc. (HURA) Monday reported positive data from Phase 1-2 study of Kineta Inc.'s KVA12123 and TuHURA's mechanism of IFx-Hu2.0 in advanced melanoma.
In the Phase I-II VISTA-101 study, KVA12123 is being evaluated alone and in combination with pembrolizumab in patients with advanced solid tumors. KVA12123 was found to be generally safe and well tolerated in all monotherapy and combination arms, with no dose-limiting toxicities observed. Additionally, KVA12123 demonstrated a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile at all dose levels.
TuHURA also announced data from the study of its IFx-Hu2.0 in patients with advanced treatment refractory Melanoma who progressed while on checkpoint inhibitor (CPI) therapy. Results showed that following treatment with IFx-Hu2.0, 3 of 4 heavily pre-treated patients with advanced Melanoma who were resistant to anti-PD-1-based therapy, achieved clinically meaningful, durable anti-tumor responses following re-administration of a CPI.
These data were presented at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL.
"We look forward to that anticipated initiation of our Phase 3 accelerated approval trial in first line treatment of patients with advanced or metastatic Merkel cell carcinoma targeted for later this quarter", stated James Bianco, President and Chief Executive Officer of TuHURA Biosciences.
In December last year, TuHURA had entered into a merger agreement with Kineta with closing of the transaction expected in the second quarter of 2025.
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